Pregnancy of Pendine in details
Pendine crosses the placenta. In a small study (n=6), the umbilical/maternal plasma concentration ratio was ~1.74. Neonatal concentrations declined quickly after delivery and at 24 hours of life were ~27% of the cord blood concentrations at birth (Pendine neonatal half-life ~14 hours) (Ohman 2005). Pregnancy registry outcome data following maternal use of Pendine during pregnancy is limited (Holmes 2012). Folic acid supplementation is recommended during pregnancy in women using Pendine (Borgelt 2016; Picchietti 2015).
Pendine is used off-label for the treatment of restless leg syndrome; however, current guidelines note there is insufficient evidence to recommend its use in pregnant women for this indication (Picchietti 2015). Pharmacological agents should not be used for the treatment of alcohol use disorder in pregnant women unless needed for the treatment of acute alcohol withdrawal or a coexisting disorder.
Patients exposed to Pendine during pregnancy are encouraged to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry by calling 1-888-233-2334. Additional information is available at www.aedpregnancyregistry.org.
Pendine breastfeeding
Benefit should outweigh risk. Excreted into human milk: Yes Comments: -The effects in the nursing infant are unknown. -Limited information indicates that maternal doses up to 2.1 g daily produce relatively low levels in infant serum. -Breastfed infants should be monitored for drowsiness, adequate weight gain, and developmental milestones, especially in younger, exclusively breastfed infants and when using combinations of anticonvulsant or psychotropic drugs.
See references
References for pregnancy information
- "Product Information. Neurontin (Pendine)." Parke-Davis, Morris Plains, NJ.
- Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
- Cerner Multum, Inc. "Australian Product Information." O 0
References for breastfeeding information
- Cerner Multum, Inc. "Australian Product Information." O 0
- United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL: http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT." ([cited 2013 -]):
- "Product Information. Neurontin (Pendine)." Parke-Davis, Morris Plains, NJ.
- Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
References
- DailyMed. "GABAPENTIN: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
- PubMed Health. "Neurontin: This section provide the link out information of drugs collectetd in PubMed Health. ". http://www.ncbi.nlm.nih.gov/pubmedhe... (accessed September 17, 2018).
- Human Metabolome Database (HMDB). "Gabapentin: The Human Metabolome Database (HMDB) is a freely available electronic database containing detailed information about small molecule metabolites found in the human body.". http://www.hmdb.ca/metabolites/HMDB0... (accessed September 17, 2018).
Reviews
Consumer reviews
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Information checked by Dr. Sachin Kumar, MD Pharmacology
